AB0456 BARICITINIB AS MONOTHERAPY FOR TREATMENT OF RHEUMATOID ARTHRITIS: SUMMARY OF DATA FROM FIVE REAL-WORLD DATA SOURCES
Authors: C. J. Edwards, A. Finckh, T. Takeuchi, A. Kleyer, E. Haladyj, C. Laedermann, J. Gerwien, T. Treuer, L. Zaremba-Pechmann, J. S. Smolen
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> EULAR recommendations suggest that use of interleukin-6 inhibitors and Janus kinase (JAK) inhibitors are preferred in rheumatoid arthritis (RA) when combination therapy with conventional synthetic disease modifying antirheumatic drugs (csDMARDs) is not indicated due to intolerance of csDMARDs. Monotherapy data for the JAK1/JAK2 inhibitor baricitinib (BARI) in patients with inadequate response to csDMARDs or biologic DMARDS (bDMARDs) are limited. <h3>Objectives</h3> To present an overview of baseline characteristics and effectiveness outcomes for patients with moderate-to-severe RA receiving BARI as monotherapy and combination therapy for up to 1 year in real world European settings. <h3>Methods</h3> BARI-related real-world data from available European registries, long-term observational studies and retrospective chart review, obtained from published sources or investigators, were reviewed. Baseline and effectiveness data, separately from each source, were reviewed for patients who received BARI as monotherapy and for those receiving BARI in combination with csDMARDs with findings presented descriptively as mean ± standard deviation (SD) or number (%) of patients. No statistical modelling was applied. Disease activity score for 28-joint count (DAS-28) low disease activity (LDA) and remission data were collected in ORBIT-RA, BSRBR-RA and the Erlangen Baricitinib cohort; and Clinical Disease Activity Index (CDAI) LDA and remission data were collected in RA-BE-REAL, ORBIT-RA and SCQM-RA. <h3>Results</h3> In BARI cohorts, monotherapy was used by 51.0% of patients in RA-BE-REAL, 61.5% in ORBIT-RA, 60.1% in SCQM-RA, 39.4% in BSRBR-RA and 67.6% in the Erlangen Baricitinib cohort. Across all databases, most patients were female, and in general, patients who received BARI as monotherapy appeared to be older, with a longer disease duration and numerically larger likelihood of previous treatment with a bDMARD than those who received the drug in combination (Table 1). Available LDA and remission rates from patients with data in the different databases are shown in the Figure 1; 40.7–78.4% of patients receiving BARI monotherapy and 33.3–80.8% receiving BARI in combination achieved either LDA or remission states at 1 year. <h3>Conclusion</h3> Approximately 40–78% of patients achieved LDA or remission after up to 1 year of monotherapy across the different data sources and populations with RA, although the numbers of patients with data to up to 1 year were small for most registries. These findings suggest that BARI monotherapy is a suitable treatment option for patients with RA. <h3>Reference</h3> [1] Gilbert B, et al. Ann Rheum Dis 2022 <h3>Acknowledgements</h3> We thank Dr Benoit Gilbert for his contribution to the study. <h3>Disclosure of Interests</h3> Christopher John Edwards Speakers bureau: Abbvie, BMS, Biogen, Celgene, Fresenius Kabi, Galapagos, Gilead, Janssen, Lilly, Pfizer, MSD, Novartis, Roche, Samsung, Sandoz, Sanofi, UCB, Consultant of: Has received honoraria and has attended advisory boards from/for Abbvie, BMS, Biogen, Celgene, Fresenius Kabi, Galapagos, Gilead, Janssen, Lilly, Pfizer, MSD, Novartis, Roche, Samsung, Sandoz, Sanofi, UCB, Grant/research support from: Abbvie, BMS, Biogen, Celgene, Fresenius Kabi, Galapagos, Gilead, Janssen, Lilly, Pfizer, MSD, Novartis, Roche, Samsung, Sandoz, Sanofi, UCB, Axel Finckh Speakers bureau: Abbvie, BMS, Eli-Lilly, Galapagos, Pfizer, MSD, Novartis, Sandoz, and UCB, Consultant of: Has received honoraria and has attended advisory boards from/for Abbvie, BMS, Eli-Lilly, Galapagos, Pfizer, MSD, Novartis, Sandoz, and UCB, Grant/research support from: Abbvie, BMS, Eli-Lilly, Galapagos, Pfizer, MSD, Novartis, Sandoz, and UCB, Tsutomu Takeuchi Speakers bureau: AbbVie, Astellas Pharma, Eisai, Eli Lilly Japan, Gilead, and Pfizer Japan, Consultant of: Has received consulting fees from AbbVie, Astellas Pharma, Eli Lilly Japan, and Gilead, and has received honoraria from AbbVie, Astellas Pharma, Eisai, Eli Lilly Japan, Gilead, and Pfizer Japan, Arnd Kleyer Speakers bureau: Abbvie, BMS, Eli-Lilly, Galapagos, Pfizer, Novartis, and UCB, Consultant of: Has received honoraria and has attended advisory boards from/for Abbvie, BMS, Eli-Lilly, Galapagos, Pfizer, Novartis, and UCB, Grant/research support from: Abbvie, BMS, Eli-Lilly, Galapagos, Pfizer, Novartis, and UCB, Ewa Haladyj Shareholder of: Minor shareholder of Eli Lilly and Company, the manufacturer of baricitinib, Employee of: Employee of Eli Lilly and Company, Cedric Laedermann Shareholder of: Minor shareholder of Eli Lilly and Company, the manufacturer of baricitinib, Employee of: Employee of Eli Lilly and Company, Jens Gerwien Shareholder of: Minor shareholder of Eli Lilly and Company, the manufacturer of baricitinib, Employee of: Employee of Eli Lilly and Company, Tamas Treuer Shareholder of: Minor shareholder of Eli Lilly and Company, the manufacturer of baricitinib, Employee of: Employee of Eli Lilly and Company, Liliana Zaremba-Pechmann Consultant of: Contractor at HaaPACS GmbH providing services to Eli Lilly and Company., Employee of: Contractor at HaaPACS GmbH providing services to Eli Lilly and Company., Josef S. Smolen Speakers bureau: Has received honoraria for speaking engagements from Abbvie, Galapagos/Gilead, Novartis-Sandoz, BMS, MSD, Samsung, Sanofi, Celltrion, Chugai, R-Pharma and Lilly, Consultant of: Has received honoraria for consultations from Abbvie, Galapagos/Gilead, Novartis-Sandoz, BMS, MSD, Samsung, Sanofi, Celltrion, Chugai, R-Pharma and Lilly, Grant/research support from: Has received research grants to his institution from Abbvie, Astra-Zeneca and Lilly.